Azelastine impurity 63 CAS CATO-C4X-139663
| CAS No. | CATO-C4X-139663 |
| Molecular Formula | C29H30ClN3O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Azelastine impurity 63 (C29H30ClN3OHCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a process- or degradation-related impurity, Azelastine impurity 63 (CAS CATO-C4X-139663, C29H30ClN3OHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
As a certified reference material (CRM), Azelastine impurity 63 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C29H30ClN3O HCl |
| Molecular Weight | 508.49 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Azelastine Standards
- Azelastine EP Impurity E (Z-Isomer) (CAS 105279-16-1)
- Azelastine Impurity 46 (CAS 109386-70-1)
- Azelastine EP Impurity B (CAS 110406-94-5)
- Azelastine Impurity 52 (CAS 1107016-94-3)
- Azelastine USP RC B HCI (CAS 117078-69-0)
- Azelastine Impurity 30 (CAS 117078-70-3)
- Azelastine-13C,d3 (CAS 1217019-80-1)
- Azelastine Impurity 17 (CAS 1239312-56-1)
Recommended Standards
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- N-Cyclopropyl-4-bromo-3-methylbenzenesulfonamide (CAS 876875-59-1)
- Rac1 Inhibitor F56, control peptide (CAS 1315378-77-8)
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